Air delivery system

ABSTRACT

An air delivery system includes a controllable flow generator, a primary controller, and an auxiliary controller. The flow generator is operable to generate a supply of pressurized breathable gas to be provided to a patient for treatment. The primary controller is associated with at least one primary control feature to select at least a first aspect of operation of the flow generator. The auxiliary controller is associated with at least one auxiliary control feature to select at least a second aspect of operation of the flow generator. The second aspect selected by the auxiliary controller is different than the first aspect selected by the primary controller. The primary and auxiliary controllers may be interchangeably usable to control operation of the flow generator.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.60/703,457, filed Jul. 29, 2005, which is incorporated herein byreference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a flow generator used in the treatment,e.g., of Sleep Disordered Breathing (SDB) with CPAP or Non-InvasivePositive Pressure Ventilation (NIPPV).

BACKGROUND OF THE INVENTION

A flow generator typically includes a housing with an integrated controlpanel for controlling the delivery of pressurized air to be provided toa patient for treatment. Treatment may be provided in various forms,from both simple CPAP systems to more complex non-invasive positivepressure ventilation (NIPPV), such as a Bi-level pressurized gasdelivery system. The flow generator may be structured to administer onlyone form of treatment, or the flow generator may be structured toadminister various forms of treatment.

Regardless of the type of flow generator, the control panel of the flowgenerator allows a clinician and/or patient to adjust the operatingparameters or settings of the flow generator for a particular treatment.When the treatment is more complex, the control panel may be relativelyadvanced with multiple menus and features. If the operating parametersfor a treatment are not appropriately selected, e.g., selected by anuntrained patient, the treatment may be ineffective and/or harmful tothe patient, or the patient simply will not use the apparatus.

Known control panels provide security codes to prevent the patient frominappropriately adjusting certain operating parameters. However, if thepatient learns the security codes and/or the security codes are notimplemented, the patient can access the same operating parameters as atrained clinician. Therefore, a need has developed in the art to provideimprovements to known flow generators to prevent inappropriate selectionof operating parameters.

SUMMARY OF THE INVENTION

One aspect of the invention is directed towards an air delivery systemincluding a flow generator with interchangeable controllers to controloperation of the flow generator, wherein one of the controllers includesbasic features for use by a patient and the other of the controllersincludes more advanced features for use by a trained clinician.

Another aspect of the invention relates to an air delivery systemincluding a controllable flow generator, a primary controller, and anauxiliary controller. The flow generator is operable to generate asupply of pressurized breathable gas to be provided to a patient fortreatment. The primary controller is associated with at least oneprimary control feature to select at least a first aspect of operationof the flow generator. The auxiliary controller is associated with atleast one auxiliary control feature to select at least a second aspectof operation of the flow generator. The second aspect selected by theauxiliary controller is different than the first aspect selected by theprimary controller. The primary and auxiliary controllers may beinterchangeably usable to control operation of the flow generator.

Yet another aspect of the invention relates to an air delivery systemincluding a controllable flow generator and a primary controller. Theflow generator is operable to generate a supply of pressurizedbreathable gas to be provided to a patient for treatment. The primarycontroller is detachably mountable to the flow generator. The controlleris associated with at least one primary control feature to select orcontrol at least a first aspect of operation of the flow generator.

Yet another aspect of the invention relates to an air delivery systemincluding a flow generator and a primary controller. The flow generatoris structured to generate a supply of pressurized breathable gas. Theflow generator is programmed with basic flow generator control featuresand advanced flow generator control features. The primary controller isonly in communication with at least one of the basic control features ofthe flow generator.

Yet another aspect of the invention relates to an air delivery systemincluding a flow generator and a blood glucose monitor. The flowgenerator is operable to generate a supply of pressurized breathable gasto be provided to a patient for treatment. The blood glucose monitor isdetachably mountable to the flow generator.

Yet another aspect of the invention relates to an air delivery systemincluding a controllable flow generator operable to generate a supply ofpressurized breathable gas to be provided to a patient for treatment.The flow generator is operable in a continuous pressure delivery modeand a variable pressure delivery mode. At least one controller isconfigured to operate the flow generator in one of the continuouspressure delivery mode or the variable pressure delivery mode.

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIG. 1 is a perspective view of an air delivery system constructedaccording to an embodiment of the present invention, the air deliverysystem including a flow generator and interchangeable controllers;

FIG. 2 is a perspective view of an air delivery system constructedaccording to another embodiment of the present invention;

FIG. 3 is a perspective view of an air delivery system constructedaccording to still another embodiment of the present invention;

FIG. 4 is a schematic view of an air delivery system constructedaccording to yet another embodiment of the present invention;

FIG. 5A is a plan view of a touchscreen display configured for a basiccontroller according to another embodiment of the present invention; and

FIG. 5B is a plan view of a touchscreen display configured for anadvanced controller according to another embodiment of the presentinvention.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

FIG. 1 illustrates an air delivery system 10 constructed according to anembodiment of the present invention. The air delivery system 10 includesa controllable flow generator 12 operable to generate a supply ofpressurized breathable air to be provided to a patient for treatment,e.g., of Sleep Disordered Breathing (SDB) with CPAP or Non-InvasivePositive Pressure Ventilation (NIPPV).

The air delivery system 10 provides interchangeable controllers 14 and16 to control operation of the flow generator 12. One controller 14includes basic features for use by the patient, and the other controller16 includes more advanced features for use by a trained clinician. Thisarrangement prevents the patient from selecting inappropriate operatingparameters of the flow generator 12, as discussed in greater detailbelow.

Flow Generator

As shown in FIG. 1, the flow generator 12 includes a housing 18 thatsupports a blower. As is known in the art, the blower is operable todraw a supply of air into the housing through one or more intakeopenings and provide a pressurized flow of air at an outlet 20.

The supply of pressurized air is delivered to the patient via an airdelivery conduit 22 that includes one end coupled to the outlet 20 ofthe flow generator 12 and an opposite end coupled to a patient interface24 (e.g., see FIG. 2).

The patient interface 24 comfortably engages the patient's face andprovides a seal. The patient interface 24 may have any suitableconfiguration as is known in the art, e.g., full-face mask, nasal mask,oro-nasal mask, mouth mask, nasal prongs, etc. Also, any suitableheadgear arrangement may be utilized to comfortably support the patientinterface in a desired position on the patient's face.

Interchangeable Primary and Auxiliary Controllers

As noted above, the flow generator 12 is controllable by interchangeablecontrollers 14 and 16. Both controllers 14 and 16 are compatible withthe flow generator 12 and may be interchangeably useable to controloperation of the flow generator 12.

Also, a removable or interchangeable controller allows the controller tobe installed into a replacement flow generator without having toreprogram as patient information may be stored in the removablecontroller.

As shown in FIG. 1, each of the controllers 14 and 16 is in the form ofa hand-held device that may be wirelessly communicated with the flowgenerator 12. A suitable protocol controls whether the controller 14 orcontroller 16 operates to select operational aspects of the flowgenerator. For example, a “registration” button may be provided on theflow generator 12 that is configured to learn the operating frequency ofa controller, e.g., radio frequency wireless technology.

Each controller 14 and 16 is operable to receive input, e.g., inputsignals, and to control operation of the flow generator 12 based oninput signals. The controllers 14, 16 include a control panel 26, 28that provides a display screen 30, 32 and one or more control features34, 36, e.g., rotatable knob and buttons, respectively, that provideinput signals. The control features 34, 36 of each controller 14, 16 maybe manually selected to adjust operating parameters of the flowgenerator 12. As illustrated, the housing 18 of the flow generator 12provides a recess 38, e.g., in the top wall, adapted to removably hold aselected one of the controllers 14, 16.

In the illustrated embodiment, one controller 14 is a primary controllerthat is operable to receive input signals from primary control features34 to control operation of the flow generator 12. That is, the primarycontroller 14 includes relatively basic control features 34 adapted tocontrol relatively basic aspects of the flow generator 12. The primarycontroller 14 is adapted for use by one who is relatively untrained,e.g., patient, to prevent the control of advanced aspects of the flowgenerator 12 that could alter the effectiveness of the treatment and/orcause harm to the patient. Also, the problem of patients being able tolearn how to enter a program mode is ameliorated over current devices.

The other controller 16 is an auxiliary controller that is operable toreceive input signals from auxiliary control features 36 to controloperation of the flow generator 12. That is, the auxiliary controller 16includes relatively advanced control features 36 adapted to controlrelatively advanced aspects of the flow generator 12. The auxiliarycontroller 16 may also include basic control features similar to thoseprovided by the primary controller 14. In the illustrated embodiment,the auxiliary controller 16 provides more control features than theprimary controller 14. Regardless, the auxiliary controller 16 providescontrol features that are different than the basic features provided bythe primary controller 14, thereby allowing control of aspects notaccessible by the primary controller 14. The auxiliary controller 16 isadapted for use by one, e.g., clinician, who is relatively trained inbreathing treatment to allow control of advanced aspects of the flowgenerator 12 in order to tailor and/or adjust treatment provided to thepatient. Furthermore, a service technician may have a controller versionthat allows the service technician to diagnose motor and/or circuitboard operations, perform testing, and/or service the flow generator.

Thus, the flow generator 12 provides separate clinical and patient use.In an embodiment, the primary controller 14 is usable by a patient tooperate the flow generator 12 in a manner that has been alreadypre-programmed by a trained clinician. This facilitates operation, andprevents the patient from changing the operating parameters.

The trained clinician pre-programs the flow generator 12 with theauxiliary controller 16. As noted above, the auxiliary controller 16allows access to advanced features, e.g., via clinical menus, to programthe flow generator 12 for a particular treatment. The auxiliarycontroller 16 may allow access to a memory that stores preferredoperating parameters for a variety of treatments. The auxiliarycontroller 16 can then control the flow generator 12 based on the storedoperating parameters in the memory for the selected treatment.Alternatively, the operating parameters for a selected treatment may beentered manually through the auxiliary controller 16. Further, theauxiliary controller 16 may allow access to a log of the patient's usefor tracking purposes. This separate clinical/patient arrangement of thesystem allows the clinician to monitor operation and adjust operatingparameters of the flow generator 12 without patient interference.

In an embodiment, the relatively basic controller 14 may be configuredto control start, stop, and delay timer operations. When the flowgenerator 12 is registered with the relatively advanced controller 16,the relatively basic controller 14 still functions but the relativelyadvanced controller 16 can override the relatively basic controller 14.The relatively advanced controller 16 may also have patient setup anddiagnostic functions such as adjusting pressure, checking patientcompliance, and/or usage data. The relatively advanced controller 16 maybe deregistered from the flow generator 12 once the flow generator 12has been operated with the relatively basic controller 14 for more thanone sleep session.

It is noted that a flow generator 12 may be controllable by a singlecontroller or multiple controllers, with each of controllers havingcontrol features suitable for a particular treatment. For example, onecontroller may be usable to operate the flow generator as a simple CPAPdevice, one controller may be usable to operate the flow generator as amore advanced VPAP device, etc. Thus, the flow generator may be upgradedby communicating a new controller with the flow generator 12.

“Plug and Play” Arrangement

The air delivery system may provide a “plug and play” arrangementwherein the patient can simply communicate a controller with the flowgenerator 12 to automatically configure the flow generator 12 for aparticular treatment. For example, the system may include controller tooperate the flow generator as a CPAP device, and a controller to operatethe flow generator as a VPAP device. Each controller would have a uniqueidentifying feature so that the flow generator 12 can recognize whichcontroller is communicated to the flow generator 12. Moreover, thecontroller can optimize operation of the flow generator 12 for thespecified treatment.

Controller with Clock/Alarm

As noted above, the controller 14, 16 for the flow generator 12 may bewirelessly communicated with the flow generator 12. This arrangementallows the patient and/or clinician to easily adjust operatingparameters of the flow generator 12 without being adjacent to the flowgenerator 12. Moreover, this arrangement allows the flow generator 12and the controller 14, 16 to be in placed in separate locations.

For example, FIG. 2 illustrates an embodiment wherein the controller 214is placed on a bedside table 80 and the flow generator 212 is placedunder the table 80 away from the controller 214. As illustrated, thecontroller 214 includes a stand 82 structured to maintain it in agenerally upright position on the table 80. Additionally, the controller214 is structured to function as a clock with an alarm and/or radio. Inuse, the flow generator 212 can operate under the table 80 where it isconcealed and the noise during use is less disturbing to the patient.Meanwhile, the patient can wirelessly control the flow generator 212 bythe controller 214 which doubles as an clock, alarm, and/or radio.

Controller with Integral Blood Glucose Monitor

FIG. 3 illustrates an arrangement that includes a flow generator 312 anda removably attachable blood glucose monitor 314. The monitor 314 may bestored within a recess 338 provided in the housing 318 of the flowgenerator 312. As illustrated, the monitor 314 includes a control panel326 and a recess 390 adapted to receive one of the patient's fingers forperforming a blood glucose test. Information from the monitor 314 may becommunicated to a physician via the flow generator. In an embodiment,the monitor 314 may adapt therapeutic pressure to optimize patientventilation according to blood glucose levels.

In the illustrated embodiment, control features 334 for operating theflow generator 312 are provided on the housing 318. However, the controlfeatures 334 may be incorporated into the monitor 314 in a manner asdescribed above.

Medicine Delivery Module

In another embodiment, the flow generator may include an add-on orintegral medicine delivery module that delivers medicinal drug (e.g.,insulin) into the air delivery path. The medicinal drug may includeatomized, aerosol, and/or particulate medication, and the medicinal drugmay be delivered into the air delivery path anywhere between the flowgenerator and the patient interface. In an embodiment, the medicinedelivery module may be integrated with the controller and a bypass tubemay add the drug into the air delivery path.

Input/Output to Couple Flow Generator and Controller

In illustrated embodiments, the controller 14, 214 for the flowgenerator 12, 212 may be wirelessly communicated with the flow generator12, 212. However, the controller 14, 214 may be communicated with theflow generator 12, 212 in any other suitable manner.

For example, as schematically shown in FIG. 4, the flow generator 12 mayinclude an input 50, and each controller 14 may include an output 52(e.g., a communication port or an electrical contact) adapted toremovably engage the input 50 to communicate each controller 14 with theflow generator 12. In an embodiment, the input may be provided withinthe recess 38 of the flow generator housing 18 shown in FIG. 1, and theoutput of the controller removably engages the input when the controlleris removably inserted into the recess 38. The system may be disabled ifa controller is not properly engaged with the flow generator. In anotherembodiment, the input and output are coupled via a cable.

Controller and Patient Monitors

The controller may be adapted to receive information from one or morepatient monitors monitoring one or more patient parameters, e.g.,patient's heart rate, breathing effort, etc. The patient and/orclinician may adjust the operating parameters of the flow generatorbased on the monitored parameters and/or the flow generator mayautomatically update the operating parameters based on the monitoredparameters.

Programmable Controller

The controller may be programmable to operate other devices, e.g.,television, stereo, etc. That is, the controller may be programmed viaself learning to function as a remote control for the television,stereo, etc. and may interface with wireless smart wiring in the home tocontrol lighting, etc.

Flow Generator with Single Controller

In an embodiment, the flow generator may be provided with a singleremovable controller that may be used by the patient and/or clinician.Thus, the controller may form a common unit that incorporates primaryand auxiliary controllers. The common unit may be selectively attachableto and detachable from the flow generator in a manner as describedabove. Moreover, the auxiliary controller may only be accessible usingan electronic key, e.g., only available at a health clinic, provided toonly a licensed clinician or health provider.

In another embodiment, the single controller may be used by theclinician to program the flow generator, and the flow generator may besupplied to the patient without the controller so the patient cannotadjust the operating parameters.

In still another embodiment, the flow generator and the controller maybe sold separately from one another. That is, the patient may purchasethe controller separately from the flow generator depending on desiredcontrol features and/or treatment. Also, the patient could rent a flowgenerator when traveling, e.g., overseas, and therefore only travel withthe controller which makes travel more convenient.

In yet another embodiment, the flow generator may be upgradable orsimply changeable between AUTOSET® (generically known as auto-adjustingmode), CPAP, VPAP® (generically known as bi-level mode), etc, by usingdifferent controllers or a single controller that can select the desiredoperating mode. That is, the patient can upgrade a basic flow generatorthat is programmed and structured to operate in a plurality of modes(e.g., AUTOSET®, CPAP, VPAP®, etc., all available from ResMed) by usinga new controller, and hence make the flow generator work like anAUTOSET®, CPAP, VPAP®, etc. The flow generator can be upgraded with ahardware upgrade, i.e., using a different controller, and/or a softwareupgrade, i.e., upgrading software of a single controller.

Controller Usable in Plurality of Flow Generators

In still another embodiment, the flow generator may include a singlepatient controller and a single technician controller. Moreover, thetechnician controller may be used in a plurality of flow generators.Thus, the technician may use a single controller to adjust the operatingparameters of different flow generators.

Controller with Touchscreen Display

In another embodiment, the controller may have a touchscreen display,which may be configured to display functions for operating certain typesof flow generators and/or for certain user levels. The display mayinclude a relatively large touchscreen with a configurable backgroundthat shows simple menus and information, and start/stop buttons. Theclinician can set up the display to suit the user and/or the user canselect which functions need to be displayed, i.e., buttons frequentlyused by the user. For example, FIG. 5A illustrates an embodiment of atouchscreen display 60 that is configured to include simple functionsfor a basic controller, and FIG. 5B illustrates an embodiment of atouchscreen display 62 that is configured to include more complexfunctions for a more advanced controller; e.g., clinician controller.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. In addition, while the invention hasparticular application to patients who suffer from OSA, it is to beappreciated that patients who suffer from other illnesses (e.g.,congestive heart failure, diabetes, morbid obesity, stroke, barriatricsurgery, etc.) can derive benefit from the above teachings. Moreover,the above teachings have applicability with patients and non-patientsalike in non-medical applications.

1-44. (canceled)
 45. An air delivery system, comprising: a controllableflow generator operable to generate a supply of pressurized breathablegas to be provided to a patient for treatment; and a controller adaptedfor wireless communication with the flow generator to control at least afirst aspect of operation of the flow generator.
 46. The air deliverysystem according to claim 45, wherein the controller is a separate anddistinct structure from the flow generator.
 47. The air delivery systemaccording to claim 45, wherein the controller is in the form of ahand-held device.
 48. The air delivery system according to claim 45,wherein the flow generator includes a mounting portion adapted tosupport the controller.
 49. The air delivery system according to claim45, wherein the controller includes a clock, an alarm, and/or a radio.50. The air delivery system according to claim 45, wherein thecontroller includes a stand structured to maintain the controller in agenerally upright position on a support surface.
 51. The air deliverysystem according to claim 45, wherein the flow generator includes aregistration feature to identify an operating frequency of thecontroller.
 52. The air delivery system according to claim 45, whereinthe controller includes a configurable touchscreen display.
 53. The airdelivery system according to claim 45, wherein the controller includesone or more control features to control one or more aspects of operationof the flow generator.
 54. The air delivery system according to claim45, wherein the controller and the flow generator are placed in separateand distinct locations from one another.
 55. The air delivery systemaccording to claim 45, wherein the flow generator is positioned in aconcealed location away from the controller.
 56. An air delivery system,comprising: a controllable flow generator operable to generate a supplyof pressurized breathable gas to be provided to a patient for treatment;and a controller to control operation of the flow generator, thecontroller being a separate and distinct structure from the flowgenerator and adapted to wirelessly connect with the flow generator. 57.The air delivery system according to claim 56, wherein the controller isin the form of a hand-held device.
 58. The air delivery system accordingto claim 56, wherein the controller includes a clock, an alarm, and/or aradio.
 59. The air delivery system according to claim 56, wherein theflow generator includes a registration feature to identify an operatingfrequency of the controller.
 60. The air delivery system according toclaim 56, wherein the controller includes one or more control featuresto control one or more aspects of operation of the flow generator. 61.The air delivery system according to claim 56, wherein the controllerand the flow generator are placed in separate and distinct locationsfrom one another.
 62. The air delivery system according to claim 56,wherein the flow generator is positioned in a concealed location awayfrom the controller.
 63. An air delivery system, comprising: acontrollable flow generator operable to generate a supply of pressurizedbreathable gas to be provided to a patient for treatment; and acontroller adapted for wireless communication with the flow generator toallow control of the flow generator, wherein the flow generator islocated in a concealed location with respect to the controller.
 64. Theair delivery system according to claim 63, wherein the controller is aseparate and distinct structure from the flow generator.
 65. A methodfor operating a flow generator system, the flow generator systemincluding a flow generator to generate a supply of pressurizedbreathable gas to be provided to a patient for treatment and acontroller adapted for wireless communication with the flow generator,the method comprising: positioning the flow generator in a concealedlocation with respect to the controller; and controlling operation ofthe flow generator with the controller by wireless communication.